Hemespec Check Set
FDA 510(k) K800852 · Helena Laboratories
510(k) numberK800852
Submission
- Device name
- Hemespec Check Set
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- April 15, 1980
- Decision date
- May 2, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRZ – Calibrator For Hemoglobin And Hematocrit Measurement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8165
- Specialty
- Hematology
Other 510(k)s with product code KRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052101 | C.F.A.S. (Calibrator for Automated Systems) HBA1CKRZ · Abbreviated | Roche Diagnostics | 08/26/2005SE |
| K041130 | CDS Hematology Calibrator (CDS Cal)KRZ · Abbreviated | Clinical Diagnostic Solutions, Inc. | 06/10/2004SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | Alko Diagnostic Corp. | 12/18/1996SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | Alko Diagnostic Corp. | 07/24/1995SE |
| K902892 | Cell-Dyn CalibratorKRZ · Traditional | Unipath , Ltd. | 09/10/1990SE |
| K896921 | Raichem TM Hemoglobin CalibratorKRZ · Traditional | Reagents Applications, Inc. | 01/25/1990SE |
| K893984 | Hgb-Cal Set/MultipleKRZ · Traditional | R&D Systems, Inc. | 08/15/1989SE |
| K883851 | Msi-Cal 8KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
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| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
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Questions and answers
When was Hemespec Check Set cleared by the FDA?
Hemespec Check Set (K800852) received a 510(k) decision of Substantially Equivalent on May 2, 1980, 17 days after the submission was received.
What is the product code of K800852?
The FDA product code is KRZ – Calibrator For Hemoglobin And Hematocrit Measurement, a Class II (moderate risk) device regulated under 21 CFR 864.8165.